Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.

NCT02134470 | Unknown

• 1 other identifier: BISP-SALIVA-2014
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

It is generally accepted that chemical testing of biologic fluids is the most objective means of diagnosis of drug use. In recent years saliva has attracted much attention. The prime advantage of saliva is that it offers non-invasive, stress-free and real-time repeated sampling whereas blood collection is undesirable, difficult and expensive. In addition, it is known that androgens such as testosterone can be assayed in saliva, as these steroids pass the endothelial-epithelial barriers by passive diffusion. Nevertheless, the correlations of blood, urine and saliva concentrations are not well documented. In recent reviews, it is pointed out that salivary hormone analysis could be a promising method for sports medicine and doping control, but much work is needed before the use of saliva samples in this area receives the acceptance. According to recent studies the increase of testosterone concentration in saliva is significantly higher than alterations of steroid concentrations (or ratios) in blood or urine. Saliva concentration may therefore serve as screening parameter to select suspicious cases for further target evaluation (e.g. by IRMS). This may be beneficial to identify cases of transdermal administration of low steroid doses. It is therefore the aim of the present project to detect administered testosterone in saliva and compare these levels to those in blood and urine. The intention is not to detect high dosage but low dosage abuse of testosterone, as a single-dose by patch application. From the practical point of view saliva could offer a complementary specimen for a pre-screening of testosterone. So it could be assumed that salivary testosterone exceed upon plasma and/or urine levels. So the present study could be the base for a new method to preselect the suspicious samples for testosterone abuse.

Conditions

Circadian; Exercise; Testosterone

Keywords

saliva; blood; urine

Outcome Measures

Primary Outcomes (1)

• Salivary testosterone concentration

  Salivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application.

  2 weeks

Secondary Outcomes (2)

• Serum testosterone

  2 weeks

• Circulating microRNA in blood plasma

  2 weeks

Other Outcomes (1)

• Testosterone in hairs

  4 weeks

Study Arms (1)

Testosterone

EXPERIMENTAL

Chemical testing of saliva is an objective method to quantify steroid hormones. Recent studies indicate that salivary testosterone is significantly higher than in other body fluids. Therefore, saliva may serve as pre-screening parameter to select suspicious cases for further target evaluation. The aim of the present project is to detect administered testosterone in saliva and compare these levels to those in blood and urine. Therefore, each participant represents its own control.

Drug: Testosterone supplementation

Interventions

Testosterone supplementation DRUG

Low-dose testosterone supplementation will be facilitated by using hormone patches. For pharmacokinetic aspects circadian profiles of saliva/blood/urine will be measured under native conditions and under exogene hormone application. In addition, cross-reactivity of a standardized exercise bout and hormone application will be of further interest.

Testosterone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male
• healthy
• informed consent

You may not qualify if:

• any metabolic, cardiovascular, pulmonary disorder
• neoplastic or hormonal disorders
• active sports competitor
• disorders which hinder cycling ergometry

Sponsors & Collaborators

• Paracelsus Medical University: lead
• Technical University of Munich: collaborator

Study Sites (1)

Technische Universität München

Munich, Bavaria, 80809, Germany

Location

Related Publications (2)

• Schonfelder M, Hofmann H, Anielski P, Thieme D, Oberhoffer R, Michna H. Gene expression profiling in human whole blood samples after controlled testosterone application and exercise. Drug Test Anal. 2011 Oct;3(10):652-60. doi: 10.1002/dta.360.

  PMID: 22031502 BACKGROUND

• Thieme D, Rautenberg C, Grosse J, Schoenfelder M. Significant increase of salivary testosterone levels after single therapeutic transdermal administration of testosterone: suitability as a potential screening parameter in doping control. Drug Test Anal. 2013 Nov-Dec;5(11-12):819-25. doi: 10.1002/dta.1536. Epub 2013 Oct 25.

  PMID: 24167110 BACKGROUND

Related Links

• Institute of Preventive Pediatrics

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Martin Schönfelder, Dr.

  Paracelsus Medical Private University Salzburg, AUT

  PRINCIPAL INVESTIGATOR

• Hande Hofmann, Dr.

  Technische Universität München, GER

  PRINCIPAL INVESTIGATOR

• Detlef Thieme, Dr.

  Institute of Doping Analysis und Sports Biochemistry Dresden in Kreischa, GER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Institute, Research Institute of Molecular Sports Medicine and Rehabilitation

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 9, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

DE (1)